EXTENDED TREATMENT OF MULTIPLE SCLEROSIS
Methods for extended treatment of multiple sclerosis are described.
1 - 17 . (canceled)
18 . A method of treating a subject having multiple sclerosis (MS), the method comprising administering, to the subject, a first course of a therapeutically effective amount of a VLA-4 binding antibody, wherein the first course is a plurality of doses of a VLA-4 binding antibody administered once a month for at least 24 months, and then after at least two months administering at least one additional course of VLA-4 binding antibody wherein the additional course comprises a plurality of doses of a therapeutically effective amount of a VLA-4 binding antibody administered once a month for at least three months.
19 . The method of claim 18 , wherein after at least 3 months, the at least one additional course of VLA-4 binding antibody is administered.
20 . The method of claim 18 , wherein after at least 4 months, the at least one additional course of VLA-4 binding antibody is administered.
21 . The method of claim 18 , wherein after at least 6 months, the at least one additional course of VLA-4 binding antibody is administered.
22 . The method of claim 18 , wherein the subject has a type of multiple sclerosis selected from the group consisting of chronic progressive multiple sclerosis, primary-progressive (PP) multiple sclerosis, secondary progressive multiple sclerosis, and progressive relapsing multiple sclerosis.
23 . The method of claim 18 , wherein the VLA-4 binding antibody inhibits VLA-4 interaction with VCAM-1.
24 . The method of claim 18 , wherein the VLA-4 binding antibody is natalizumab.
25 . The method of claim 18 , wherein the VLA-4 binding antibody is human or humanized.
26 . The method of claim 18 , wherein the VLA-4 binding antibody competes with HP-1/2 or natalizumab for binding to VLA-4.
27 . The method of claim 18 , wherein each dose of the first course is between 200 and 400 mg.
28 . The method of claim 18 , wherein each dose of the at least one additional dose is between 200 and 400 mg.
29 . The method of claim 18 , wherein the VLA-4 binding antibody is administered in combination with a second therapeutic agent during the first course of administration.
30 . The method of claim 18 , wherein the VLA-4 binding antibody is administered in combination with a second therapeutic agent during the at least one additional course of administration.
31 . The method of claim 29 , wherein the second therapeutic agent is an interferon, a glatiramer acetate, a fumarate, an anti-CD20 antibody, a mixtoxantrone, a chemotherapeutic, a corticosteroid, an immunoglobulin, a statin, an azathioprine, or a TNF antagonist.
32 . The method of claim 30 , wherein the second therapeutic agent is an interferon, a glatiramer acetate, a fumarate, an anti-CD20 antibody, a mixtoxantrone, a chemotherapeutic, a corticosteroid, an immunoglobulin, a statin, an azathioprine, or a TNF antagonist.
33 . The method of claim 18 , wherein the first course and the at least one additional course of administrations are IV administrations.
34 . The method of claim 18 , wherein the first course of VLA-4 binding antibody is administered for at least 30 months prior to the at least one additional course of administrations.
35 . The method of claim 18 , wherein the first course of VLA-4 binding antibody is administered for at least 36 months prior to the at least one additional course of administrations.
36 . The method of claim 18 , wherein the first course of VLA-4 binding antibody is administered for at least 48 months prior to the at least one additional course of administrations.
37 . The method of claim 18 , wherein the subject is administered the VLA-4 binding antibody according to a regimen that is effective to achieve at least 50% alpha4 integrin receptor saturation in the subject prior to the at least one additional course of administration.
38 . The method of claim 18 , wherein administration of the at least one additional course of VLA-4 binding antibody results in a decreased rate of relapse as compared to the rate of relapse following administration for the prior at least 24 months.
39 . The method of claim 18 , wherein administration of the at least one additional course of VLA-4 binding antibody results in a decreased EDSS score as compared to the EDSS score following administration for the prior at least 24 months.
40 . A method of treating a subject having MS, the method comprising: selecting a patient who was previously administered a first course of a VLA-4 binding antibody, wherein the first course is a plurality of doses of a VLA-4 binding antibody administered once a month for at least 24 months; and then at least two months after the first course, administering to the patient at least one additional course of VLA-4 binding antibody, wherein the additional course comprises a plurality of doses of a therapeutically effective amount of a VLA-4 binding antibody administered once a month for at least three months.